CMC Project Planner

Objective

Essential Functions

• Develop and maintain comprehensive project plans including schedules, resource allocation, task dependencies, and timelines for multiple ongoing projects.
• Collaborate with cross-functional teams, including CMC and production, quality assurance, regulatory and clinical to align project objectives and deliverables.
• Track progress, identify potential bottlenecks, and implement corrective actions to ensure that project milestones are achieved on time.

• Monitor and document daily activities and tasks for all assigned projects, ensuring seamless execution and adherence to established timelines.
• Utilize project management software to assign tasks, update progress, and provide real-time visibility to stakeholders at all levels.
• Ensure compliance with industry and regulatory standards during project execution and planning.

• Serve as the central point of contact for project updates and status reports, ensuring all stakeholders are informed of progress and any deviations.
• Prepare clear and concise reports, presentations, and project dashboards for internal and external stakeholders.
• Facilitate meetings to review project timelines, address challenges, and confirm completion of tasks.

• Identify and document potential risks and challenges that could affect project timelines or quality, and propose appropriate mitigation strategies.

• Maintain robust documentation of all project-related activities, decisions, and changes to ensure traceability and accountability.

Qualifications

Education / Experience

• Bachelor’s degree in life sciences or a related field. A certification in project management (e.g., PMP) is a plus.
• Minimum 2 years of project planning or coordination experience, preferably in the pharmaceutical, biotechnology, or radiopharmaceutical industries.
• Extra preference for CMC  and supply integration backgrounds in the biotech or pharmaceutical industries
• Proficiency in project management tools such as Microsoft Project, Office Timeline, or equivalent software.

Knowledge / Skill / Ability

• Knowledge of regulatory requirements and compliance standards in the radiopharmaceutical or pharmaceutical sectors is highly desirable.
• Strong organizational skills with the ability to manage multiple projects and priorities simultaneously.
• Effective communication and interpersonal skills, with the ability to work collaboratively in a team-oriented environment.
• Curiosity, learning agility and adaptability.
• Outstanding ability to communicate technical information to both technical and non-technical audiences.
• Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities.
• Ability to manage and prioritize multiple programs to ensure on-time delivery with meticulous quality.
• Ability to become well-versed with relevant medical and imaging concepts and terminology.
• Ability to facilitate meetings and discussions in person and virtually.

Work Environment

• May be required to sit or stand for long periods of 8+ hours a day while performing duties.  
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.